Here is the SQF7 viewpoint -
SQFI Guidance
RE: 2.8.3 Allergen Cleaning and Sanitation Practices
The SQF Code requires validation and verification of cleaning and sanitizing procedures for the product
contact equipment, and therefore the use of finished product testing for validation of cleaning is not
considered adequate. A program of verification needs to be built on an initial validation study that
identifies the target allergen(s) , threshold levels, and the severity of contamination, and shows the
cleaning process and testing used are effective to give the desired results consistently. Once the
cleaning process has been validated as effective, a verification/monitoring/inspection program shall be
established to assure that the validated cleaning process is being used, is maintained and effective.
Validation
The purpose of validation is to prove that the cleaning process employed is effective in removing the
allergen of concern. This proof requires evidence that the specific allergen was in fact removed, or
reduced to an acceptable level by the cleaning procedure. Therefore, only an allergen specific test will
provide that evidence.
The acceptable validation testing methods involve the use of a test specific to the allergen being
removed. These generally require the use of a test method which uses an antigen (the allergen) and an
antibody specific to the antigen. One example of the antigen and antibody test is the enzyme linked
immuno-assay or ELISA method. The ELISA method can be either quantitative or qualitative and can be
conducted in a laboratory or with test kits available for in plant use; either is acceptable. ELISA test kits
are available from several manufacturers and are commonly used in the food processing industry.
Lateral flow test devices also use an ELISA-based method and are also effective in detecting specific
allergens. While lateral flow devices are qualitative only, most have sensitivities around 10 parts per
million(ppm) and are available for most of the common allergens and are designed for use in a plant
environment.
Both the ELISA tests and lateral flow test kits have been accepted by recognized allergen research
scientists and meet the requirements for sanitation validation of the SQF Code. It must be noted that
there may be other ‘acceptable’ tests for validation methods that can be used but the test must meet
the “allergen specific” criteria or provide some other evidence that the validation is effective. The SQF
Institute does not endorse any particular technology or methodology and relies on the facility to provide
the evidence of a scientifically validated and effective cleaning method. Like any validation of any food
safety control, periodic re-validation is required to account for any changes that may have occurred.
Not all allergens have specific test kits available which includes some fin fish and allergens that have
been modified by fermentation, heating or hydrolysis.
Verification
Once a validated cleaning method has been shown to remove the allergenic material of concern, the
facility must verify that the validated procedures were used each time. This verification must be
documented by a responsible person from the facility who has been trained in the validated cleaning
method. The most common method used is direct observation of the validated cleaning procedure
during the sanitation process. Another acceptable verification method is the use of highly sensitive
swabs that test for proteins. These recently developed swabs will detect total protein at approximately
20 ppm. Since these devices only test for total protein and not specific allergens, they are not
acceptable for validation but will serve to verify that equipment has been thoroughly cleaned. There are
also sensitive ATP test swabs available however the presence of ATP does not indicate the presence of
protein which is the allergenic material. The use of these total protein swabs or the ATP sensitive swabs
must be calibrated with the validated cleaning procedure by using them immediately after the validated
method is used and recording the results of both the allergen specific test and the protein or ATP swab
test. It is also to ensure surface swabbing is occurring at corners, joins, and crevices in the equipment
as well as open surfaces, to check for protein held up in equipment.
